CEPH, interesting local article here from West Chester, Penna.
<<Provigil ineffective treating ADHD, according to study
By Erin Mendell, Staff Writer August 01, 2000
WEST CHESTER -- Cephalon Inc.’s stock prices took a plunge Monday following news that a clinical study showed Provigil, the drug company’s flagship product, was not effective in treating adults with attention deficit hyperactivity disorder, commonly called ADHD.
Cephalon’s stock closed at $40.31, down 36 percent from Friday’s closing price of $62.75.
Provigil was approved by the Food and Drug Administration in 1998 as a once-a-day treatment to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, a sleep disorder.
"I think that the market today is really overreacting to this news," said Peter Ginsberg, an analyst with U.S. Bancorp Piper Jaffray in Minneapolis. Ginsberg said he is still recommending that investors buy Cephalon shares, because Provigil sales don’t depend on its use to treat ADHD.
Sheryl Williams, a spokeswoman for Cephalon, agreed with Ginsberg’s assessment. She said stock prices fell because people are more familiar with the ADHD treatment market than with the market for excessive daytime sleepiness. "I’m not sure people understand what (excessive daytime sleepiness) means," Williams said.
She said Cephalon’s most recent clinical study concerning Provigil as a possible treatment for ADHD was just part of a larger, ongoing study. Williams said the company had no plans of abandoning the study. "People will look very carefully at this study," she said. But "it certainly isn’t the news that we wanted to hear."
ADHD affects approximately 3 to 6 percent of the United States’ population.
The negative results of the study are not a big setback for Cephalon, Williams said. The company is also doing studies that could result in Provigil being used for excessive daytime sleepiness associated with disorders other than narcolepsy, such as sleep apnea, a disorder that causes sufferers to wake up several times during the night because they have stopped breathing.
Williams said Cephalon is currently studying the drug’s effectiveness in shift workers -- people, such as nurses and police officers, whose jobs sometimes require them to work odd hours.
The National Sleep Foundation estimates that 35.2 million Americans suffer from a disorder associated with excessive daytime sleepiness.
Williams said the company plans to file a supplemental new drug application in 2001 so that the drug can be prescribed to treat excessive daytime sleepiness related to these other situations. A company must file a supplemental new drug application if it wants to market a drug for a use different than the use the FDA has already approved the drug for.
Williams said all the studies concerning expanding Provigil’s use for treating excessive daytime sleepiness have had positive results so far.
Provigil is a stimulant, and doctors prescribe other stimulants, such as Ritalin, to treat both excessive daytime sleepiness and ADHD.
There’s at least one positive aspect to the drop in Cephalon’s stock prices. "It certainly makes Cephalon an attractive buy," Williams said.
Cephalon bought Anesta Corp. of Salt Lake City, Utah in July. Anesta’s flagship product is a drug-delivery system that helps manage pain caused by breakthrough cancer. The technology can be used in connection with other drugs, such as outpatient anesthesia and motion sickness drugs, as well. Williams said that means Cephalon can use that technology to diversify what it does, and that means the company can also diversify its risk.>>
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